On February 4, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that more mature interim TACTI-002 clinical data will be presented at the 34th German Cancer Congress taking place in Berlin from 19th to 22nd February 2020 (Press release, Immutep, FEB 4, 2020, View Source [SID1234553867]).

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The data relates to use of the Company’s lead product candidate eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3 protein based on the LAG-3 immune control mechanism, as part of a combination treatment with pembrolizumab. It will be presented by TACTI-002 clinical trial Principal Investigator, Dr. Bernhard Doger of START Madrid, Spain on 19 February at 5 pm CEST. The abstract was submitted as a late-breaking abstract.

The presentation entitled, ‘Initial results from a Phase II study (TACTI-002) in metastatic non-small cell lung or head and neck carcinoma patients receiving eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab’ will be contemporaneously released via an ASX announcement and made available on the Company’s website at the time of the congress on www.immutep.com/investors-media/presentations.html.

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line HNSCC or NSCLC in first and second line.

On February 4, 2020 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported its financial results for the fourth quarter and full-year ended December 31, 2019 and provided full-year 2020 financial expense guidance (Press release, Neurocrine Biosciences, FEB 4, 2020, View Source [SID1234553852]).

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"I am very pleased with the accomplishments of Neurocrine Biosciences this past year, including our quarterly and full-year business results. We anticipate an exciting year ahead as we continue to build a leading global neuroscience-focused biopharmaceutical company," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2020, we will continue to focus on educating healthcare providers, caregivers and patients to help even more people suffering from the debilitating movements caused by tardive dyskinesia. In addition, we look forward to helping patients with Parkinson’s disease with the anticipated approval of opicapone and the potential expanded use of elagolix to help women with uterine fibroids. By mid-2020, our activities position us to have three approved treatments in four indications and three additional ongoing pivotal studies."

Fourth Quarter and Full-Year 2019 Financial Highlights

Fourth Quarter and Full Year Net Product Sales Highlights:

INGREZZA (valbenazine) net product sales for the fourth quarter and full year 2019 were $238 million and $753 million respectively, representing an increase of over 80% versus prior period comparisons.
Continued strength in INGREZZA new patient additions in the fourth quarter.
End of fourth quarter 2019 days-on-hand channel inventory increased relative to the third quarter 2019 due to timing of quarter-end purchases resulting in an approximate $11 million benefit to net product sales.
Financial Highlights:

Research and Development (R&D) investment increased in the fourth quarter of 2019 versus the fourth quarter of 2018 primarily as a result of the Company’s ongoing activities in congenital adrenal hyperplasia studies and in gene therapy partially offset by prior year spending on the Tourette syndrome program.
Selling, General and Administrative (SG&A) investment increased in the fourth quarter of 2019 versus the fourth quarter of 2018, primarily as a result of the patient-focused disease state awareness campaign, "Talk About TD", and an increase in the Branded Pharmaceutical Drug, or BPD, fee expense.
In-Process Research and Development (IPR&D) expense of $36 million in the fourth quarter of 2019 reflects the Company’s collaboration with Xenon Pharmaceuticals specific to NBI-921352 (XEN901) for epilepsy.
Fourth quarter of 2019 GAAP net income and diluted earnings per share (EPS) were $34 million and $0.35, respectively, compared to $18 million and $0.19, respectively, in the fourth quarter of 2018.
Fourth quarter of 2019 non-GAAP net income and diluted earnings per share (EPS) were $102 million and $1.05, respectively, compared to $38 million and $0.40, respectively, in the fourth quarter of 2018.
As of December 31, 2019, the Company had cash, cash equivalents and marketable securities totaling $970 million.
A reconciliation of GAAP to non-GAAP quarterly financial results can be found in Tables 3 through 5 at the end of this earnings release.

Recent Events

In December 2019, the Company entered into a license and collaboration agreement with Xenon, a clinical-stage biopharmaceutical company. Pursuant to the terms of the agreement, the Company gained an exclusive license to NBI-921352, a clinical-stage selective Nav1.6 sodium channel inhibitor with potential in SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other forms of epilepsy, including focal epilepsy. Upon filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in mid-2020, the Company intends to start a Phase II study in SCN8A-DEE patients in 2H 2020.
In January 2020, the Company announced an option agreement that was originally signed in 2019 with Idorsia granting the Company an option to license ACT-709478, a potent, selective, orally-active, and brain penetrating T-type calcium channel blocker, in clinical development for the treatment of a rare pediatric epilepsy. A Phase II study in a rare pediatric epilepsy is planned in 2H 2020 dependent upon IND application acceptance by the FDA in mid-2020.
Full-Year 2020 Financial Guidance

GAAP and Non-GAAP expense guidance range reflects increased investment in R&D programs including three registrational programs, meaningful investments across early stage programs including Voyager and Xenon collaborations, continued investment in INGREZZA and marketing costs associated with the anticipated launch of opicapone.
GAAP-only guidance includes approximately $100 million of share-based compensation and a $20 million expected milestone payment to BIAL connected with the expected approval of opicapone by the FDA during the second quarter. GAAP-only guidance does not include any other potential milestones or in-process research and development costs associated with current collaborations or future business development activities.
Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 877-876-9173 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

About INGREZZA (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso, and/or other body parts.

INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release from presynaptic neurons. INGREZZA, developed in Neurocrine’s laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.

Important Safety Information
Contraindications
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

Warnings & Precautions
Somnolence
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Parkinsonism
INGREZZA may cause Parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

Adverse Reactions
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

On February 4, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the second quarter ended December 31, 2019 (Press release, Bio-Techne, FEB 4, 2020, View Source [SID1234553836]).

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Second Quarter FY2020 Snapshot

Second quarter organic revenue increased by 6% (6% reported) to $184.9 million and 9% (9% reported) in the first half of fiscal 2020 to $368.2 million.

GAAP EPS was $3.02 versus $0.45 one year ago resulting from a gain of approximately $121 million on our ChemoCentryx investment. Delivered adjusted earnings per share (EPS) of $1.08, an increase of 2% despite foreign currency exchange headwinds negatively impacting results by $0.08 or 8% in the second quarter.

Adjusted Operating Margin increased to 33.4% in the second quarter of fiscal 2020 compared to 32.5% in the second quarter of fiscal 2019.

Diagnostics and Genomics delivered organic growth of 12% in the second quarter and 14% in the first half of fiscal 2020.

As of December 1, 2019, applicable Medicare beneficiaries are now covered for the ExoDx Prostate Test.

The Company formed a new joint venture focused on providing scalable manufacturing technologies and processes needed to develop and commercialize new cell and gene therapies.

Delivered record Operating Cash Flow in the quarter and paid down $103 million of debt.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"Q2 was a solid quarter of 6% organic growth, especially considering some one-time headwinds we had over last year," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Our core retail reagents remained strong with double-digit growth in most product categories, while our Genomics’ ACD business continued growing at over 20% in Q2. As expected, China continued its trend of above 20% growth while Europe was soft year over year, especially with instrument sales. However, early in Q3, we are starting to see instrument order rates in Europe accelerate to growth rates that we are more accustomed to experiencing."

Kummeth added, "Overall, I am pleased with the team’s performance in the first half of the fiscal year. I am also encouraged by the strength in our end-markets and our excellent competitive position and look forward to executing even better in the second half of the fiscal year."

Second Quarter Fiscal 2020

Revenue

Net sales for the second quarter increased 6% to $184.9 million. Organic growth was 6% compared to the prior year, with foreign currency exchange having an unfavorable impact of 1% and acquisitions contributing 1% to revenue growth.

GAAP Earnings Results

GAAP EPS increase to $3.02 per diluted share, versus $0.45 in the same quarter last year. GAAP EPS was favorably impacted by a gain of approximately $121 million on our ChemoCentryx investment. GAAP operating income for the second quarter of fiscal 2020 increased 10% to $37.0 million, compared to $33.6 million in the second quarter of fiscal 2019. GAAP operating margin was 20.0%, compared to 19.3% in the second quarter of fiscal 2019. GAAP operating margin compared to prior year was positively impacted by volume leverage on sales growth.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.08 per diluted share, versus $1.06 in the same quarter last year, an increase of 2%. Adjusted EPS increased due to revenue growth in the quarter, which was partially offset by foreign currency headwinds. Adjusted operating income for the second quarter of fiscal 2020 increased 9% compared to the second quarter of fiscal 2019. Adjusted operating margin was 33.4%, compared to 32.5% in the second quarter of fiscal 2019. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage on sales growth.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology community. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s second quarter fiscal 2020 net sales were $141.5 million, an increase of 4% from $135.5 million for the second quarter of fiscal 2019. Organic growth for the segment was 4%, with foreign currency exchange having an unfavorable impact of 1% on revenue growth and acquisitions contributing 1% to revenue growth. Protein Sciences segment’s operating margin was 43.0% in the second quarter of fiscal 2020 compared to 43.5% in the second quarter of fiscal 2019. The segment’s operating margin compared to the prior year was negatively impacted by the acquisition of B-Mogen in Q4 of FY19 and unfavorable foreign exchange.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s second quarter fiscal 2020 net sales were $43.8 million compared to $39.3 million for the second quarter of fiscal 2019. Organic growth for the segment was 12%, with foreign currency exchange having an immaterial impact on revenue. The Diagnostics and Genomics segment’s operating margin was 2.2% in the second quarter of fiscal 2020 compared to -2.7% in the second quarter of fiscal 2019. The segment’s operating margin was favorably impacted by volume leverage.

Conference Call

Bio-Techne will host an earnings conference call today, February 4, 2020 at 8:00 a.m. CST. To listen, please dial 1-800-289-0438 or 1-323-794-2423 for international callers, and reference conference ID 2359733. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by going to:
View Source

The replay will be available from 11:00 a.m. CDT on Tuesday, February 4, 2020 until 11:00 p.m. CDT on Wednesday, March 4, 2020.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring assessments. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

On February 4, 2020 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, and Levena Biopharma, a company specialized in developing antibody drug conjugates (ADCs), reported the expanded collaboration to develop ADCs targeting humoral immuno-suppressed cancers (Press release, Navrogen, FEB 4, 2020, View Source [SID1234553853]). ADCs developed under this collaboration combine Levena’s linker and cytotoxic payload chemistry expertise along with Navrogen’s cancer-targeting antibodies discovered using its proprietary Humoral Immuno Oncology (HIO) platform technologies. Navrogen’s antibodies are able to specifically target and combat HIO-suppressed cancers that produce factors that dampen antibody-mediated immune-effector activity as well as decrease ADC internalization and subsequent release of their cytotoxic payloads which is required for killing. This collaboration will also include the use of Levena’s process development and GMP capabilities.

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"Our collaboration with the exceptional scientists at Levena has enabled us to create a number of ADCs to specifically treat HIO-suppressed cancers," stated Luigi Grasso, Ph.D., Chief Scientific Officer at Navrogen. "The expansion of this collaboration will enable us to proceed with their advancement towards clinical trials."

Tong Zhu, Ph.D., Executive Director, Chemistry at Levena commented, "we have employed several of our technologies with the Navrogen team over the past year to identify HIO-refractory ADC formats. We look forward to continue supporting their development plans that can benefit from our expertise and technologies."

On February 4, 2020 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported that Steven A. Shallcross, Chief Executive and Financial Officer, is scheduled to present at the BIO CEO & Investor Conference on Monday, February 10, 2020, at 11:00 a.m. (ET) at the New York Marriott Marquis (Wilder room) (Press release, Synthetic Biologics, FEB 4, 2020, View Source [SID1234553837]).

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A live webcast of Synthetic Biologics’ presentation may be accessed by logging onto the internet at http://www.veracast.com/webcasts/bio/ceoinvestor2020/17107426667.cfm. A replay will be archived and accessible for 90 days at the same website and at www.syntheticbiologics.com.